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Article

Access_open Changes in the Medical Device’s Regulatory Framework and Its Impact on the Medical Device’s Industry: From the Medical Device Directives to the Medical Device Regulations

Journal Erasmus Law Review, Issue 2 2019
Keywords Medical Device Directive, Medical Device Regulation, regulatory, European Union, reform, innovation, SPCs, policy
Authors Magali Contardi
AbstractAuthor's information

    Similar to pharmaceutical products, medical devices play an increasingly important role in healthcare worldwide by contributing substantially to the prevention, diagnosis and treatment of diseases. From the patent law perspective both, pharmaceutical products and a medical apparatus, product or device can be patented if they meet the patentability requirements, which are novelty, inventiveness and entail industrial applicability. However, regulatory issues also impact on the whole cycle of the innovation. At a European level, enhancing competitiveness while ensuring public health and safety is one of the key objectives of the European Commission. This article undertakes literature review of the current and incoming regulatory framework governing medical devices with the aim of highlighting how these major changes would affect the industry at issue. The analysis is made in the framework of an on-going research work aimed to determine whether SPCs are needed for promoting innovation in the medical devices industry. A thorough analysis the aforementioned factors affecting medical device’s industry will allow the policymakers to understand the root cause of any optimal patent term and find appropriate solutions.


Magali Contardi
PhD candidate; Avvocato (Italian Attorney at Law).
Article

Access_open Access and Reuse of Machine-Generated Data for Scientific Research

Journal Erasmus Law Review, Issue 2 2019
Keywords machine-generated data, Internet of Things, scientific research, personal data, GDPR
Authors Alexandra Giannopoulou
AbstractAuthor's information

    Data driven innovation holds the potential in transforming current business and knowledge discovery models. For this reason, data sharing has become one of the central points of interest for the European Commission towards the creation of a Digital Single Market. The value of automatically generated data, which are collected by Internet-connected objects (IoT), is increasing: from smart houses to wearables, machine-generated data hold significant potential for growth, learning, and problem solving. Facilitating researchers in order to provide access to these types of data implies not only the articulation of existing legal obstacles and of proposed legal solutions but also the understanding of the incentives that motivate the sharing of the data in question. What are the legal tools that researchers can use to gain access and reuse rights in the context of their research?


Alexandra Giannopoulou
Institute for Information Law (IViR) – University of Amsterdam.
Article

Access_open Modern Intellectual Property Governance and Openness in Europe: A Long and Winding Road?

Journal Erasmus Law Review, Issue 2 2019
Keywords Intellectual Property, governance, data sharing
Authors Nikos Koutras
AbstractAuthor's information

    In the last decade a trend towards more ‘openness’ in terms of collaborations and access to knowledge has been observed in many different sectors and contexts. Along the spectrum of openness one can find many different varieties, such as open innovation, co-creation, open science (combined with open access and open data) and open source. Even traditionally rather ‘closed’ actors, such as publishing houses and the pharmaceutical industry, are gradually catching up and are trying to develop mechanisms to cope with this trend towards openness. Both public and private actors encounter challenges in combining this trend towards openness with the management of intellectual property rights (IPRs). Although a strong willingness may exist to collaborate, open up and share knowledge and data, IPRs often create boundaries and limitations towards cutting-edge collaborations and initiatives for openness and sharing. Over time, companies, universities, public research organisations, etc. have developed certain models to allow for openness while safeguarding ways to protect their IPRs. Yet the legal framework is often lagging behind and does not appear to reflect the socio-economic trend towards openness; in many jurisdictions, changes to IP legislation have rather focused on strengthening of the rights of IP owners. But this is not necessarily a problem as stakeholders tend to find workarounds in their day-to-day practice. This special issue aims to further the discussion about modern governance of IPRs in Europe and to explore different perspectives on how openness could be operationalised within the context of IP protection.


Nikos Koutras
Postdoctoral Researcher, Faculty of Law, University of Antwerp.
Article

Access_open Text and Data Mining in the EU ‘Acquis Communautaire’ Tinkering with TDM & Digital Legal Deposit

Journal Erasmus Law Review, Issue 2 2019
Keywords Web harvesting, data analysis, text & data mining, TDM, computational text
Authors Maria Bottis, Marinos Papadopoulos, Christos Zampakolas e.a.
AbstractAuthor's information

    Text and Data Mining (hereinafter, TDM) issue for the purpose of scientific research or for any other purpose which is included in the provisions of the new EU Directive on Copyright in the Digital Single Market (hereinafter, DSM). TDM is a term that includes Web harvesting and Web Archiving activities. Web harvesting and archiving pertains to the processes of collecting from the web and archiving of works that reside on the Web. In the following analysis we will elaborate briefly upon provisions in EU Copyright law which were discussed during the proposal for a new Directive on Copyright in the DSM as well as provisions which are included in the text of art.3 and art.4 of the new Directive 2019/790/EU per TDM. In addition, the following analysis presents legislation in very few EU Member States which pertains to TDM and preceded the rulings of Directive 2019/790/EU. Digital legal deposit remarkable examples from EU Member States are also presented in this paper. The example of Australia is also presented below hereto because it is one of the oldest and most successful worldwide. The National Library of Australia’s digital legal deposit is state-of-the-art.


Maria Bottis
Associate Professor, Department of Archives, Library Science and Museology, Ionian University, Corfu, Greece.

Marinos Papadopoulos
Attorney-at-Law, PhD, MSc, JD, Independent Researcher, Athens, Greece.

Christos Zampakolas
Archivist/Librarian, PhD, MA, BA, Independent Researcher, Ioannina, Greece.

Paraskevi Ganatsiou
Educator, MA, BA, Coordinator of Educational Projects in the Prefecture of Ionian Islands, Corfu, Greece.

    This article relies on the premise that to understand the significance of Open Access Repositories (OARs) it is necessary to know the context of the debate. Therefore, it is necessary to trace the historical development of the concept of copyright as a property right. The continued relevance of the rationales for copyright interests, both philosophical and pragmatic, will be assessed against the contemporary times of digital publishing. It follows then discussion about the rise of Open Access (OA) practice and its impact on conventional publishing methods. The present article argues about the proper equilibrium between self-interest and social good. In other words, there is a need to find a tool in order to balance individuals’ interests and common will. Therefore, there is examination of the concept of property that interrelates justice (Plato), private ownership (Aristotle), labour (Locke), growth of personality (Hegel) and a bundle of rights that constitute legal relations (Hohfeld). This examination sets the context for the argument.


Nikos Koutras
Postdoctoral Researcher, Faculty of Law, University of Antwerp.
Article

Access_open Impact of International Law on the EU Customs Union

Journal Erasmus Law Review, Issue 3 2019
Keywords European Union, customs union, international law, customs legislation, autonomous standards
Authors Achim Rogmann
AbstractAuthor's information

    This contribution examines the various international instruments, in both hard and soft law, that have been established by international organisations such as the WTO and WCO and scrutinises how they have been implemented into EU legislation governing the EU Customs Union, thus demonstrating the substantial influence of international instruments on the Customs Union. As the relevant international instruments affect not only the traditional elements of European customs law, but also the EU’s entire export control regime and the framework of the internal market, this contribution demonstrates, moreover, how the Customs Union functions in a globalised world.


Achim Rogmann
Achim Rogmann, LL.M is professor of law at the Brunswick European Law School at Ostfalia Hochschule fur angewandte Wissenschaften.
Article

Access_open Joinder of Non-Consenting Parties: The Singapore International Commercial Court Approach Meets Transnational Recognition and Enforcement

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial courts, international business courts, third parties, third party joinder, recognition and enforcement
Authors Drossos Stamboulakis and Blake Crook
AbstractAuthor's information

    In this article we explore the approach of the Singapore International Commercial Court (the ‘SICC’) to jurisdiction and joinder of non-consenting parties, and way that any resulting judgments are likely to be treated by foreign enforcing courts. This novel juncture arises as international commercial courts, such as the SICC, rely predominantly upon party autonomy to enliven their jurisdiction over disputants. This does not require any territorial link of the parties or the dispute to the host jurisdiction (Singapore). At the same time, however, the SICC is granted a mandate under Singaporean law to join non-consenting parties, again with no necessary territorial link. Where such joinder occurs, any resulting judgment is likely to face significant difficulties if recognition and enforcement is sought outside of Singapore. To support this argument, we first set out the ways in which non-consenting disputants may be joined to proceedings before the SICC, and offer some initial thoughts on how these powers are likely to be exercised. Second, we argue that any such exercise of jurisdiction – that lacks either territorial or consent-based jurisdiction grounds – is unlikely to gain support internationally, by reference to transnational recognition and enforcement approaches, and the SICC’s most likely recognition and enforcement destinations. Finally, we offer some concluding remarks about the utility of international commercial court proceedings against non-consenting parties, including the possibility they may impact on domestic recognition and enforcement approaches in foreign States.


Drossos Stamboulakis
B.Com, LLB (Hons) (Monash); LLM (EMLE); Law Lecturer, USC School of Law (University of the Sunshine Coast, Australia)

Blake Crook
PhD Candidate, Faculty of Law (University of Melbourne, Australia), B.Com (Acc), LLB (Hons) (Sunshine Coast).
Editorial

Access_open International Business Courts in Europe and Beyond: A Global Competition for Justice?

Journal Erasmus Law Review, Issue 1 2019
Keywords international business courts, justice innovation, justice competition, global commercial litigation, private international law
Authors Xandra Kramer and John Sorabji
Author's information

Xandra Kramer
Xandra Kramer, Professor of Private Law at Erasmus University Rotterdam, and of Private International Law, Utrecht University.

John Sorabji
John Sorabji, Senior Teaching Fellow, UCL, London/Principal Legal Adviser to the Lord Chief Justice and the Master of the Rolls.

Sir Geoffrey Vos
Chancellor of the High Court of England and Wales.
Article

Access_open The Emergence of International Commercial Courts in India: A Narrative for Ease of Doing Business?

Journal Erasmus Law Review, Issue 1 2019
Keywords Commercial contracts, Enforcement, Jurisdiction, Specialized courts, India
Authors Sai Ramani Garimella and M.Z. Ashraful
AbstractAuthor's information

    The liberal globalised order has brought increased focus on the regulation of international commerce, and especially dispute resolution. Enforcement of contracts has been a concern largely owing to the insufficiencies of the legal systems, especially relating to the institutional structure, and it holds true for India as well. The commercial courts mechanism – international and domestic – with innovative features aimed at providing expedited justice is witnessing much traction. India, similar to many other jurisdictions, legislated in favour of specialized dispute resolution mechanisms for commercial disputes that could help improve the procedures for enforcement of contracts. This research attempts to critique the comparable strengths and the reform spaces within the Indian legislation on commercial courts. It parses the status of commercial dispute resolution in India especially in the context of cross-border contracts and critiques India’s attempt to have specialised courts to address commercial dispute resolution.


Sai Ramani Garimella
Sai Ramani Garimella, PhD, is assistant professor of the faculty of legal studies at the South Asian University in New Delhi.

M.Z. Ashraful
M.Z. Ashraful is the research student at South Asian University in New Delhi.
Article

Access_open International Commercial Courts in France: Innovation without Revolution?

Journal Erasmus Law Review, Issue 1 2019
Keywords international commercial court, dispute resolution, business court, Brexit, judicial system
Authors Alexandre Biard
AbstractAuthor's information

    In 2018, in the wake of Brexit, the French legal profession took several important measures to strengthen the competitiveness of France and the French legal system, and to make Paris an attractive go-to-point for businesses when the latter have to deal with international commercial litigation. When taking a closer look at it, Brexit is only the top of the iceberg, and has mostly served as a catalyst. Reasons explaining the development of international commercial courts in France are manifold. They are consequences of long-standing efforts aimed at boosting the French judicial marketplace to adapt it to the requirements of globalization and to the expectations of multinational corporations. The setting-up of the French international business courts has made several procedural adjustments necessary. Although the latter undoubtedly represent clear innovations, they however do not constitute a full-blown revolution. France has indeed decided to maximize already-existing procedural rules, combined with a new organisational format inspired by the Common Law tradition. If it remains too early to draw clear conclusions on the impact of these new developments, it is essential to keep our ears to the ground, and to be forward-looking. We should carefully consider the possible side-effects on the French justice system considered as a whole, and in particular wonder whether these international commercial courts might in the future open the door to broader far-reaching evolutions within the judicial system. Finally, the multiplication of international business courts across Europe nowadays triggers some questions concerning the role and potential added value of an EU initiative in this domain.


Alexandre Biard
Postdoctoral researcher, Erasmus University Rotterdam.
Article

Access_open The Conduit between Technological Change and Regulation

Journal Erasmus Law Review, Issue 3 2018
Keywords technology, socio-technological change, money, windmill, data
Authors Marta Katarzyna Kołacz and Alberto Quintavalla
AbstractAuthor's information

    This article discusses how the law has approached disparate socio-technological innovations over the centuries. Precisely, the primary concern of this paper is to investigate the timing of regulatory intervention. To do so, the article makes a selection of particular innovations connected with money, windmills and data storage devices, and analyses them from a historical perspective. The individual insights from the selected innovations should yield a more systematic view on regulation and technological innovations. The result is that technological changes may be less momentous, from a regulatory standpoint, than social changes.


Marta Katarzyna Kołacz
Marta Katarzyna Kołacz, Ph.D. Candidate in the Department of Private Law, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.

Alberto Quintavalla
Alberto Quintavalla, LL.M., Ph.D. Candidate in the Rotterdam Institute of Law and Economics, Erasmus School of Law, Erasmus University Rotterdam, The Netherlands.
Article

Access_open Right to Access Information as a Collective-Based Approach to the GDPR’s Right to Explanation in European Law

Journal Erasmus Law Review, Issue 3 2018
Keywords automated decision-making, right to access information, right to explanation, prohibition on discrimination, public information
Authors Joanna Mazur
AbstractAuthor's information

    This article presents a perspective which focuses on the right to access information as a mean to ensure a non-discriminatory character of algorithms by providing an alternative to the right to explanation implemented in the General Data Protection Regulation (GDPR). I adopt the evidence-based assumption that automated decision-making technologies have an inherent discriminatory potential. The example of a regulatory means which to a certain extent addresses this problem is the approach based on privacy protection in regard to the right to explanation. The Articles 13-15 and 22 of the GDPR provide individual users with certain rights referring to the automated decision-making technologies. However, the right to explanation not only may have a very limited impact, but it also focuses on individuals thus overlooking potentially discriminated groups. Because of this, the article offers an alternative approach on the basis of the right to access information. It explores the possibility of using this right as a tool to receive information on the algorithms determining automated decision-making solutions. Tracking an evolution of the interpretation of Article 10 of the Convention for the Protection of Human Right and Fundamental Freedoms in the relevant case law aims to illustrate how the right to access information may become a collective-based approach towards the right to explanation. I consider both, the potential of this approach, such as its more collective character e.g. due to the unique role played by the media and NGOs in enforcing the right to access information, as well as its limitations.


Joanna Mazur
Joanna Mazur, M.A., PhD student, Faculty of Law and Administration, Uniwersytet Warszawski.
Article

Access_open Privatising Law Enforcement in Social Networks: A Comparative Model Analysis

Journal Erasmus Law Review, Issue 3 2018
Keywords user generated content, public and private responsibilities, intermediary liability, hate speech and fake news, protection of fundamental rights
Authors Katharina Kaesling
AbstractAuthor's information

    These days, it appears to be common ground that what is illegal and punishable offline must also be treated as such in online formats. However, the enforcement of laws in the field of hate speech and fake news in social networks faces a number of challenges. Public policy makers increasingly rely on the regu-lation of user generated online content through private entities, i.e. through social networks as intermediaries. With this privat-ization of law enforcement, state actors hand the delicate bal-ancing of (fundamental) rights concerned off to private entities. Different strategies complementing traditional law enforcement mechanisms in Europe will be juxtaposed and analysed with particular regard to their respective incentive structures and consequential dangers for the exercise of fundamental rights. Propositions for a recommendable model honouring both pri-vate and public responsibilities will be presented.


Katharina Kaesling
Katharina Kaesling, LL.M. Eur., is research coordinator at the Center for Advanced Study ‘Law as Culture’, University of Bonn.
Article

Access_open Empirical Legal Research in Europe: Prevalence, Obstacles, and Interventions

Journal Erasmus Law Review, Issue 2 2018
Keywords empirical legal research, Europe, popularity, increase, journals
Authors Gijs van Dijck, Shahar Sverdlov and Gabriela Buck
AbstractAuthor's information

    Empirical Legal research (ELR) has become well established in the United States, whereas its popularity in Europe is debatable. This article explores the popularity of ELR in Europe. The authors carried out an empirical analysis of 78 European-based law journals, encompassing issues from 2008-2017. The findings demonstrate that a supposed increase of ELR is questionable (at best).
    Moreover, additional findings highlight:

    • An increase for a few journals, with a small number of other journals showing a decrease over time;

    • A higher percentage of empirical articles for extra-legal journals than for legal journals (average proportion per journal is 4.6 percent for legal journals, 18.9 percent for extra-legal journals);

    • Criminal justice journals, environmental journals, and economically oriented journals being more likely to publish empirical articles than other journals;

    • More prestigious journals being more likely to publish empirical articles than less-prestigious journals;

    • Older journals being more likely to publish empirical work than younger journals, but not at an increasing rate;

    • Journals being legal/extra-legal, journals in a specific field, journal ranking, or the age of the journal not making it more (or less) likely that the journal will publish empirical articles at an increasing (or decreasing) rate.
      Considering the lack of convincing evidence indicating an increase of ELR, we identify reasons for why ELR is seemingly becoming more popular but not resulting in more empirical research in Europe. Additionally, we explore interventions for overcoming the obstacles ELR currently faces.


Gijs van Dijck
Professor of Private Law at Maastricht University, the Netherlands.

Shahar Sverdlov
Law student at the Vrije Universiteit Amsterdam, the Netherlands.

Gabriela Buck
Law student at Maastricht University, the Netherlands.

Kristin Henrard Ph.D.
Kristin Henrard is professor minorities and fundamental rights in the department of International and EU law of the Erasmus School of Law in the Netherlands.

Jeremie Gilbert
Jeremie Gilbert is professor of Human Rights Law at the University of Roehampton in the UK.

    The judgment of the Inter-American Court of Human Rights in the case of Kaliña and Lokono Peoples v. Suriname is noteworthy for a number of reasons. Particularly important is the Court’s repeated citation and incorporation of various provisions of the 2007 United Nations Declaration on the Rights of Indigenous Peoples into its interpretation of the American Convention on Human Rights. This aids in greater understanding of the normative value of the Declaration’s provisions, particularly when coupled with the dramatic increase in affirmations of that instrument by UN treaty bodies, Special Procedures and others. The Court’s analysis also adds detail and further content to the bare architecture of the Declaration’s general principles and further contributes to the crystallisation of the discrete, although still evolving, body of law upholding indigenous peoples’ rights. Uptake of the Court’s jurisprudence by domestic tribunals further contributes to this state of dynamic interplay between sources and different fields of law.


Fergus MacKay JD
Article

Access_open Legal Legitimacy of Tax Recommendations Delivered by the IMF in the Context of ‘Article IV Consultations’

Journal Erasmus Law Review, Issue 2 2017
Keywords legitimacy, International Monetary Fund (IMF), Article IV Consultations, tax recommendations, global tax governance
Authors Sophia Murillo López
AbstractAuthor's information

    This contribution examines the legal legitimacy of ‘Article IV Consultations’ performed by the IMF as part of its responsibility for surveillance under Article IV of its Articles of Agreement. The analysis focuses on tax recommendations given by the Fund to its member countries in the context of Consultations. This paper determines that these tax recommendations derive from a broad interpretation of the powers and obligations that have been agreed to in the Fund’s Articles of Agreement. Such an interpretation leads to a legitimacy deficit, as member countries of the Fund have not given their state consent to receive recommendations as to which should be the tax policies it should adopt.


Sophia Murillo López
Sophia Murillo López, LL.M, is an external PhD candidate at the Erasmus University Rotterdam and a member of the ‘Fiscal Autonomy and its Boundaries’ research programme.
Article

Access_open The Questionable Legitimacy of the OECD/G20 BEPS Project

Journal Erasmus Law Review, Issue 2 2017
Keywords base erosion and profit shifting, OECD, G20, legitimacy, international tax reform
Authors Sissie Fung
AbstractAuthor's information

    The global financial crisis of 2008 and the following public uproar over offshore tax evasion and corporate aggressive tax planning scandals gave rise to unprecedented international cooperation on tax information exchange and coordination on corporate tax reforms. At the behest of the G20, the OECD developed a comprehensive package of ‘consensus-based’ policy reform measures aimed to curb base erosion and profit shifting (BEPS) by multinationals and to restore fairness and coherence to the international tax system. The legitimacy of the OECD/G20 BEPS Project, however, has been widely challenged. This paper explores the validity of the legitimacy concerns raised by the various stakeholders regarding the OECD/G20 BEPS Project.


Sissie Fung
Ph.D. Candidate at the Erasmus University Rotterdam and independent tax policy consultant to international organisations, including the Asian Development Bank.
Article

Access_open The Peer Review Process of the Global Forum on Transparency and Exchange of Information for Tax Purposes

A Critical Assessment on Authority and Legitimacy

Journal Erasmus Law Review, Issue 2 2017
Keywords Global Forum on Transparency and Exchange of Information, exercise of regulatory authority, due process requirements, peer review reports, legitimacy
Authors Leo E.C. Neve
AbstractAuthor's information

    The Global Forum on transparency and exchange of information for tax purposes has undertaken peer reviews on the implementation of the global standard of exchange of information on request, both from the perspective of formalities available and from the perspective of actual implementation. In the review reports Global Forum advises jurisdictions on required amendments of regulations and practices. With these advices, the Global Forum exercises regulatory authority. The article assesses the legitimacy of the exercise of such authority by the Global Forum and concludes that the exercise of such authority is not legitimate for the reason that the rule of law is abused by preventing jurisdictions to adhere to due process rules.


Leo E.C. Neve
Leo Neve is a doctoral student at the Erasmus School of Law, Rotterdam.
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